PROTOCOL REVIEW AND MONITORING SYSTEM Abstract The Case Comprehensive Cancer Center (Case CCC) Protocol Review and Monitoring System (PRMS) is responsible for scientific evaluation, prioritization, and monitoring of all cancer clinical research studies conducted at the Center's consortium institutions. The PRMS is independent of and complements the activities of the Institutional Review Boards and Data Safety and Toxicity Committee. The PRMS encompasses activities of the Clinical Research Disease Teams and Protocol Review and Monitoring Committee (PRMC), with close interaction between these entities. The Case CCC Clinical Research Office (CRO) oversees the PRMS, as the central coordinator of clinical trials operations (ex, Clinical Protocol and Data Management), and associated committees (PRMC, Data Safety and Toxicity, Minority Accrual, and Clinical Research Operations Committee). The CRO is a critical resource for clinical investigators across the Center?s clinical sites, Cleveland Clinic and University Hospitals. The Specific Aims are to: 1) Provide scientific review and prioritization of all applicable cancer-related clinical research protocols across Case CCC consortium institutions 2) Monitor the progress of ongoing studies to ensure that accrual is sufficient to meet scientific objectives The PRMC supports the research programs of the Case CCC by providing scientific review and feedback (including feasibility assessment), establishing prioritization, and monitoring progress of and patient accrual in active clinical research studies. The PRMC membership is selected to ensure diverse expertise relevant to cancer clinical research and is composed of clinical investigators, investigational pharmacists, registered nurses, biostatisticians, translational PhD scientists, and patient advocates from consortium member institutions. The PRMC operates as a single committee across the Case CCC consortium and reviews all new clinical cancer research protocols, including those sponsored by the Center, NCI, other NIH, industry, foundations, or other sources. These include interventional (ex, treatment, preventive, supportive, diagnostic), and non-interventional (ex, ancillary, correlative [tissue-based], and observational studies). The PRMC has authority to close ongoing studies that are not meeting accrual or performance standards and are unlikely to accomplish their scientific goals, and a structured process for accrual monitoring and evaluation is followed. All new protocols and protocol amendments that include scientific changes, such as revisions in objectives/endpoints, eligibility, treatment/dosing, biostatistics, and sample collection, are evaluated by the PRMC. In 2016, there were 588 active interventional studies at Case CCC monitored by the PRMC. The PRMC reviewed 237 new studies (full board review: 183; administrative review: 44; tissue-based: 10). The PRMC also reviewed 330 amendments. ! !